PAPER AND NeeS

SUBMISSION
Paper Submission :

• Paper submission was the most primitive mode of regulatory submission from
industry to regulatory body for review, assessment and authorization of the
medical product.

• All the required regulatory data is printed out in paper and submitted to the
regulatory authority via mail or in-personal.

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Requirements for paper submission :

• Size of paper
• Volume of dossier
• Slip sheets
• Tab sheets

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Size of paper :

• All the organizations should ensure that the size of paper should be consistent.

• It can be either A4 or letter size.?

• This requirement is to maintain the consistency of all submissions made to agency.

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Volume of dossier :

•The information submitted to agency is huge. So, practically it is impossible to incorporate all the
data in a single bundle.

•Hence the agency has decided to break down the data into different volumes for ease of review.

•Each volume should not exceed 200-250 pages.

•The division of the dossier into volumes should be meaningful.

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 Tab sheets :

•Tab sheet is a navigating tool in the paper submission.

•Tab sheet helps the reviewer to navigate specific module or section easily.

•These are the sheets which is extended towards the right side carrying a information about the
particular module or section.

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Slip sheets :

• Slip sheet is also a navigating tool in the paper submission.

• Slip sheet helps the reviewer to navigate specific subsection in a module or section easily.

• These are the sheets which are points out exact sub section in a dossier.

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DISADVANTAGES OF PAPER SUBMISSION :
•Poorly organized
•Data missing
•Difficult to search cross patients
•No decision support
•Occupies more storage area
•Difficult to store for longer period of time
•Very difficult to find information
•No security
•Hard to change information
•Lose data in case of fire exposure

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Non-eCTD electronic Submission (NeeS)

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•NeeS stands for Non-eCTD electronic Submission.

•It acts as a intermediate between paper submission and eCTD submission.

•Its is less complicated than the paper submission and comparatively more complicated than the
eCTD submission.

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Non-eCTD electronic Submissions :

• Electronic Submission without XML

• No lifecycle management

• Module specific TOCs – pdf version

• Not accepted by US-FDA

• EU and ROW acceptable format

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NeeS – why and when is it required :

• National, Mutual Recognition and Decentralized procedures

• For all submission types except pre-marketing authorization information

• For ROW countries which do not accept eCTD versions

• Often when transitioning from Paper version.

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Specifications :
•Structure of submissions: CTD format with granularity
•Folder structure: Follow the CTD structure to meet validation criteria
•File Formats:
o pdf files – v1.4 to 1.7(restrictions)
o Acrobat Reader, version 5.0 or higher
o RTF, JPEG to pdf conversion required
•CTD and Module TOCs : TOC is mandatory
•Folder and file Path length:
o No spaces allowed
o 180 characters path length acceptable (Counting starts from the first digit of the four
digits folder name in which the ctd-toc.pdf is placed)
o Do not add extensions for files

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• Use of characters:
o No spaces
o ONLY alphabets in lower case
o No special characters as dot, slash, etc

• Document requirements:
o File size
o Security
o Encryption
o Password
o Watermarks
o Stamps
o Electronic signatures

• Virus Protection
• Transmission Media: should be well labeled 13
Naming Conventions :
•ICH and EU CTD file naming conventions should be followed

•The naming convention for individual documents is determined by the location of the document
within the structure of the electronic submission – not by the content of the document

•Path length is the number of characters including the folder name, file name and extension

•File name has 2 components:

1. Fixed component/ Pre-defined

2. Variable component
o e.g emea-reponses- var.pdf

•Literature references naming conventions are based on the Harvard Style of Referencing.
o e.g : abcd-yyyypxxx (variable contents in red)

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Mandatory Specifications for NeeS :
• All documents in the NeeS dossier should be referenced from a hyperlinked Table of Contents
(TOC). Hyperlinks for each document should always be provided to the first page of the
appropriate file
• The files containing the module Tables of Content should be named m1-toc.pdf, m2-toc.pdf, m3-
toc.pdf, m4-toc.pdf and m5-toc.pdf and be located in the corresponding top level module folder
• For the application form and cover letter, there is no requirement to scan wet signatures. The
signature could in these cases appear only on the paper copy, if provided
• The fonts used in the PDF should be embedded in the PDF where possible
• Submission or file level security is not permitted. If one-time security settings or password
protection of an electronic submission is used this could constitute grounds for the rejection of
the submission
• Authorities will not accept any hardware (laptops, desktops, separate hard drives, etc.), Zipped
files should not be used when sending CDs or DVDs

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• There are two European portals in use for regulatory submissions
• Common European Submission Platform (CESP) can be used to send national or MRP/DCP
submissions
• The EMA eSubmission Gateway/Web Client should be used for submissions to the EMA in the
PSUR Single Assessment (PSUSA) procedure of Nationally Authorised Products

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Grouping Submission :

•Submissions for workshare/grouping variations across MAs are recommended to be supplied

together on a single CD/DVD. The CD/DVD should contain a top level folder called either grouping
or work sharing and clearly marked subfolders for each product that takes part in a work sharing
or grouping procedure

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 Compilation of NeeS Dossier :

1. Create sequence
2. Assign documents
3. Assign valid CTD names
4. Linking of documents
5. Create TOCs
6. Compile the sequence
7. Validate

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